Members

Submitted by admin on Tue, 09/20/2016 - 00:13
GHWP Chair :  Dr. Xu Jinghe, Deputy Commissioner, National Medical Products Administration (NMPA), People's Republic of China
GHWP Vice-Chair (Regulatory Authority): Ms. Eka Purnamasari, Director for Medical Devices Control, Ministry of Health, Indonesia
GHWP Vice-Chair (Industry): Ms. EunHee Cho, RA Director, Abbott Medical Korea, Republic of Korea

 

 

 

Brunei Darussalam 

Regulatory Authority (primary representative)

Ms. Ruby HJ HARUN
Acting Director
Healthcare Technology Department
Ministry of Health
Brunei Darussalam

Regulatory Authority (secondary representative)

Mr. Mohd Asni ABD GHANI
Senior Biomedical Engineer
Healthcare Technology Department
Ministry of Health
Brunei Darussalam

Industry            (primary representative)

Nil

Industry         (secondary representative)

Nil

Cambodia 

Regulatory Authority
(primary representative)

Mrs. Nouv Phalla
Deputy Chief (Registration Bureau)
Department of Drugs and Food
Ministry of Health
Cambodia

Regulatory Authority
(secondary representative)

Ms. Lim Phany
Deputy Chief (Registration Bureau)
Department of Drugs and Food
Ministry of Health
Cambodia

Industry
(primary representative)

Nil

Industry
(secondary representative)

Nil


Chile 

Regulatory Authority
(primary representative)

Ms. Maria Cecilia LOPEZ
Professional Medical Devices Office
Public Health Institute of Chile
Chile

Regulatory Authority
(secondary representative)

Ms. Ana Maria CONCHA 
Professional Medical Devices Office
Public Health Institute of Chile
Chile

Industry
(primary representative)

Mr. Esteban GONZALEZ
President Medical Devices Society
Chile

Industry
(secondary representative)

Mr. Luis PIZARRO
Vice President Medical Devices Society
Chile

Chinese Taipei 
 

Regulatory Authority
(primary representative)

Ms. Pei-Weng TU
Director
Division of Medical Devices and Cosmetics
Food and Drug Administration
Ministry of Health and Welfare
Chinese Taipei

Regulatory Authority
(secondary representative)

Dr. Chia-Hung CHIEN
Deputy Director
Division of Medical Devices and Cosmetics
Food and Drug Administration
Ministry of Health and Welfare
Chinese Taipei

Industry
(primary representative)

Yi-Shin LEE
Executive Director/ Chairperson of Compliance Committee
Taiwan Medical and Biotech Industry Association

Industry
(secondary representative)

Mr. Albert T.W. LI
Manager, Office of Medical Device Evaluation, Center for Measurement Standards
Industrial Technology Research Institute

Cuba Regulatory Authority
(primary representative)
Mario Cesar Muñiz Ferrer
Head of Medical Devices Department CECMED
Regulatory Authority
(secondary representative)
Yadira Álvarez Rodriguez
Specialist of Medical Devices Department CECMED
Industry
(primary representative)

Arlem Lesmes Fernández Sigler
Managing Director
COMBIOMED

Industry
(secondary representative)
Eva Maria Garcia Suárez
Senior Quality Specialist
BIOCUBAFARMA 
Egypt Regulatory Authority
(primary representative)
Rania Soliman
General manager of general administration of medical devices
Marketing authorization
Egyptian Drug Authority
Regulatory Authority
(secondary representative)
Noha Osama Elhariry
General manager of general administration of medical devices
Marketing authorization
Egyptian Drug Authority
Industry
(primary representative)
Amr Elshafi
Compliance manager
Roche Diagnostics Egypt
Industry
(secondary representative)
Heba Tork
Regulatory and quality manager
Roche Diagnostics Egypt


Hong Kong SAR, China 

Regulatory Authority
(primary representative)

Dr. Addi CHAN
Principal Medical & Health Officer (Medical Device)
Department of Health
Hong Kong SAR Government

Regulatory Authority
(secondary representative)

Dr. Ambrose WONG
Senior Medical & Health Officer (Medical Device)
Department of Health
Hong Kong SAR Government

Industry
(primary representative)

Mr. Jack WONG
RAQA Senior Director
APAC, CooperVision

Industry
(secondary representative)

Nil
 


India 

Regulatory Authority
(primary representative)

Dr V. G. Somani
Joint Drugs Controller
Central Drugs Standard Control Organisation
DGHS, MOH & FW, FDA
India

Regulatory Authority
(secondary representative)

Dr. Ravi Kant Sharma
Assistant Drugs Controller
Central Drugs Standard Control Organisation
DGHS, MOH & FW, FDA
India

Industry
(primary representative)

Ms Sumati Randeo
Director Government Affairs
Danaher Corporation
India

Industry
(secondary representative)

Vibhav Garg
VP Health Policy & Govt. Affairs,
GE India
India


Indonesia 

Regulatory Authority
(primary representative)

Eka Purnamasari
Director of Medical Device Control
Ministry of Health
Indonesia

Regulatory Authority
(secondary representative)

Ismiyati Surata
Senior Health Administrator
Ministry of Health
Indonesia

Industry
(primary representative)

Cristina Sandjaja
Secretary General
ASPAKI

Industry
(secondary representative)

Ade Herawati Purnamasari
Member in Regulation and Formulation Strategy of Gakeslab Indonesia


Japan 

Regulatory Authority
(primary representative)

MIYASAKA Tomoyuki
Deputy Director
Medical Devices Evaluation Division
Ministry of Health, Labour and Welfare (MHLW)

Regulatory Authority
(secondary representative)

KUSAKABE Tetsuya
International Coordination Officer
Pharmaceuticals and Medical Devices Agency (PMDA)

Industry
(primary representative)

YANAGIDA Yuji
Internaitonal Policy & Strategy Committee Chair
Japan Federation of Medical Devices Association (JFMDA)

Industry
(secondary representative)

ASAI Hideki
ISO/TC 210 Domestic Committee
Vice Chair
Japan Federation of Medical Devices Association (JFMDA)


Jordan 

Regulatory Authority
(primary representative)

Dr. Shatha Al-Quraan
Head of Medical Device & Equipment Dept.
Jordan Food and Drug Administration

Regulatory Authority
(secondary representative)

Dr. Saleem Al Mahrouq
Medical Device & Equipment Director
Jordan Food and Drug Administration

Industry
(primary representative)

Dr. Mohammed Saleem
Science-forum (SIPS)
Amman-Jordan

Industry
(secondary representative)

Nil

Kazakhstan

Regulatory Authority
(primary representative)

Mrs Akmaral Kabdenova
Deputy General Director
National Center for Drugs and Medical Devices Expertise
Kazakhstan

Regulatory Authority
(secondary representative)

Mr. Olzhas Akhmetsadyk
Head of Medical device testing laboratory
National Center for Expertise
Kazakhstan

Industry
(primary representative)

Nil

Industry
(secondary representative)

Nil
 

Kingdom of Bahrain 

Regulatory Authority (primary representative)

Mr Nada AI SAYEGH
Consultant/ engineering safety
National Healthcare Regulatory Authority
Kingdom of Bahrain

Regulatory Authority (secondary representative)

Nil

Industry            (primary representative)

Nil

Industry         (secondary representative)

Nil


Kingdom of Saudi Arabia 

Regulatory Authority
(primary representative)

Mr. Ali M. AL-DALAAN
Vice Executive President
Medical Devices Sector
Saudi Food & Drug Authority
Kingdom of Saudi Arabia

Regulatory Authority
(secondary representative)

Mr. Abdullah AI Rasheed
Consultant
Saudi Food & Drug Authority
Kingdom of Saudi Arabia

Industry
(primary representative)

Mr. Fahad Al Moammar
GM
Damad

Industry
(secondary representative)

Mr. Faisal Mansour Matbuli
Sr. RA Director
medtronic


Kyrgyz Republic 

Regulatory Authority
(primary representative)

Dr. Gulmira Shakirova
General Director
Department of Drug Provision and Medical Equipment
Ministry of Health
Kyrgyz Republic

Regulatory Authority
(secondary representative)

Мrs. Аinurа Abalieva
Head of Registration
Medical Devices Department
Kyrgyz Republic

Industry
(primary representative)

Nil

Industry
(secondary representative)

Nil


Laos PDR

Regulatory Authority
(primary representative)

Mr. Bounxou KEOHAVONG
Director General
Food and Drug Department
Ministry of Health
Laos PDR

Regulatory Authority
(secondary representative)

Ms. Davone Douangdany
Chief of Drug and Medical Device Control Division
Food and Drug Department
Ministry of Health
Laos PDR

Industry
(primary representative)

Ms. Quan TRAN
Vice President
Quality Assurance and Regulatory Affairs
Baxter Healthcare

Industry
(secondary representative)

 Nil


Malaysia

Regulatory Authority
(primary representative)

 

Salbiah BT Yaakop
Director of Policy, International Affairs & Industry Facilitation Division
Medical Device Authority
Ministry of Health
Malaysia

Regulatory Authority
(secondary representative)

 

Norhafizah Binti Mohd Salleh
Principal Assistant Director 
Medical Device Authority
Ministry of Health
Malaysia

Industry
(primary representative)

Ong Yean Ting
Malaysia

Industry
(secondary representative)

Tony LOW
Director of QA/RA and Human Performance
Commissioning Agents International
Malaysia

Mongolia

Regulatory Authority
(primary representative)

Mr Bayarjargal. S
Senior Biomedical Engineer
Mongolian Regulatory Agency of Standardisation and Metrology
Mongolia

Regulatory Authority
(secondary representative)

Mr Ganbaatar. Ts
Officer
Policy Planning on Health Technology
Ministry of Health and Sports
Mongolia

Industry
(primary representative)

Mr Enkhjargal. B
Professor
Biomedical Engineering Department
Mongolian University of Science and Technology
Mongolia

Industry
(secondary representative)

Nil


Myanmar

Regulatory Authority
(primary representative)

Dr Myint SEIN
Deputy Director General
Myanmar Pharmaceutical Factory
Myanmar

Regulatory Authority
(secondary representative)

Nil

Industry
(primary representative)

Nil

Industry
(secondary representative)

Nil


Pakistan

Regulatory Authority
(primary representative)

Dr. Muhammad Fakhr ud Din Aamir
Director, Medical Devices & Medicated Cosmetics
Drug Regulatory Authority
Pakistan

Regulatory Authority
(secondary representative)

Ms. Unum Zia Shamsi
Assistant Director, Medical Devices & Medicated Cosmetics
Drug Regulatory Authority
Pakistan

Industry
(primary representative)

Nadeem Hussain Alamgir
CEO/Director
RA Consultants (SMC-PVT) Limited
Pakistan

Industry
(secondary representative)

Muhammad Sohail
Manager Regulatory Affairs
Fresenius Medical Care Pakistan Private Ltd
Pakistan


People's Republic of China

Regulatory Authority
(primary representative)

Xu Jinghe
Deputy Commissioner
NMPA
People's Republic of China

Regulatory Authority
(secondary representative)

Gao Guobiao
Secretary of Leading Party Group
Center for Medical Device Evaluation
NMPA
People's Republic of China

Industry
(primary representative)

Deyuan Jiang
Senior Consultant
China Association for Medical Device Industry

Industry
(secondary representative)

Hengkun Zhao
Deputy General Manager
Shandong Weigao Group
Medical Polymer Co. Limited


Philippines
 

Regulatory Authority
(primary representative)

Maria Cecilia MATIENZO
Division Chief
Medical Non-Radiation Device Regulation Division
Bureau of Health Devices & Technology
Philippines

Regulatory Authority
(secondary representative)

Nil

Industry
(primary representative)

Johanna Gullle
BD Philippines
Philippines

Industry
(secondary representative)

Julie Anne Odarbe
Allergan Healthcare
Philippines


Republic of Kenya

Regulatory Authority
(primary representative)

Mr. Fred M. SIYOI
Registrar
Pharmacy and Poisons Board
Medical Device Safety Bureau
Ministry of Health
Republic of Kenya

Regulatory Authority
(secondary representative)

Dr. Paulyne Wairimu
Head of Medical Devices
Pharmacy and Poisons Board
Ministry of Health
Republic of Kenya

Industry
(primary representative)

Nil

Industry
(secondary representative)

Nil


Republic of Korea

Regulatory Authority
(primary representative)

Dr. Jeong-Rim Lee
Director General
Medical Device Evaluation Division
Ministry of Food and Drug Safety(MFDS)
Republic of Korea

Regulatory Authority
(secondary representative)

Dr. Hye-Won Roh
Director
Cardiovascular and Imaging Devices Division
Ministry of Food and Drug Safety(MFDS)
Republic of Korea

Industry
(primary representative)

Ms. Eun-Hee Cho
RA Director
Abbott Medical Korea
Republic of Korea

Industry
(secondary representative)

Ms. Rachel H. Chung
Head of RAQA
CONMED Korea Ltd.

Republic of Korea


Singapore 
 

Regulatory Authority
(primary representative)

Dr. Rama Sethuraman
Director, Medical Devices
Medical Devices Cluster
Health Sciences Authority
Singapore

Regulatory Authority
(secondary representative)

Ms Liew Lai Ling
Assistant Director, Diagnostic Devices Branch
Medical Devices Cluster
Health Sciences Authority
Singapore

Industry
(primary representative)

Ms. Jacqueline Cecilla Monteiro
SMF MTIG 1st  Deputy Chairman
SMF MTIG, Singapore

Industry
(secondary representative)

Ms. Jocelyn Yen
RA/QA Manager, SEA
Bard Singapore Pte. Ltd., Singapore


South Africa 

Regulatory Authority
(primary representative)

Mrs. Portia Nkambule
Chief Regulatory Officer
South African Health Products Regulatory Authority

Regulatory Authority
(secondary representative)

Dr. Dimakatso Mathibe
Senior Manager Medical Device and Radiation Control
South African Health Products Regulatory Authority

Industry
(primary representative)

Ms. Tanya Vogt
Chief Operating Officer
South African Medical Device Industry Association (SAMED)
South Africa

Industry
(secondary representative)

Ms. Madeleine PEARCE
Chair of the Regulatory Committee
SAMED & SALDA
South Africa


State of Kuwait 

Regulatory Authority
(primary representative)

Adel A. Alhajji
Ministry of Health
Biomedical Engineering Administration
State of Kuwait

Regulatory Authority
(secondary representative)

Nil

Industry
(primary representative)

Nil

Industry
(secondary representative)

Nil


Sultanate of Oman 

Regulatory Authority
(primary representative)

Dr. Mohammed Hamdan Al Rubaie
Director General
Pharmaceutical Affairs & Drug Control, Ministry of Health

Sultanate of Oman

Regulatory Authority
(secondary representative)

Eng. Faiza Al Zadjali
Ministry of Health
Sultanate of Oman

Industry
(primary representative)

Nil

Industry
(secondary representative)

Nil

Tanzania

Regulatory Authority
(Primary
representative)

Mr. Adam Mitangu Fimbo
Director General
Tanzania Medicines and Medical Devices Authority (TMDA)

Regulatory Authority
(Secondary representative)

Ms. Kissa Watson Mwamwitwa
Director of Medical Devices and Diagnostics Control
Tanzania Medicines and Medical Devices Authority (TMDA)

Industry
(Primary repressentative)

 Nil

Industry
(Secondary representative)

 Nil


Thailand 
 

Regulatory Authority
(primary representative)

Mr. Varavoot Sermsinsiri
Director
Medical Device Control Division
Food and Drug Administration
Thailand

Regulatory Authority
(secondary representative)

Mr. Nakorn TANGWANCHAREANCHAI
Post-market control supervisor
Medical Devices Control Division
Food and Drug Administration
Thailand

Industry
(primary representative)

Ms. Mallika LATAVALYA NA AYUDHAYA
Manager
Thai Medical Device Technology Industry Association
Thailand
 

Industry
(secondary representative)

Ms. Siriphan Eiamrungroj
Thailand
 

United Arab Emirates  

Regulatory Authority (primary representative)

Dr. Amal AI Awadhi
Director of Drug Department
Ministry of Health and Prevention
United Arab Emirates

Regulatory Authority (secondary representative)

Nil

Industry            (primary representative)

Mounir Haddad
General Manager
Abu Dhabi Medical Device Company
Dubai, United Arab Emirates

Industry         (secondary representative)

 Nil


Vietnam 

Regulatory Authority
(primary representative)

Nguyen Minh Tuan
Director
Department of Medical Equipment & Construction
Ministry of Health
Vietnam

Regulatory Authority
(secondary representative)

Doan Quang Minh
Expert
Department of Medical Equipment & Construction
Ministry of Health
Vietnam

Industry            (primary representative)

Nguyen Thi Thu Thuy
Johnson & Johnson
Vietnam

Industry         (secondary representative)

Cao Thi Ai Lien
Philips
Vietnam

Yemen 

Regulatory Authority
(primary representative)

Mr. Safwan Ali Al Aoudi                            
Approval director
Import department
Supreme Broad For drugs and medical appliances
Ministry of Health
Yemen

Regulatory Authority
(secondary representative)

 

 Nil

Industry
(primary representative)

Nil

Industry
(secondary representative)

Nil
 

Zimbabwe 

Regulatory Authority
(primary representative)

MS G.N. Mahlangu
Director General
Medicines Control Authority of Zimbabwe
Zimbabwe

Regulatory Authority
(secondary representative)

Mr R. Rukwata
Head
Licensing and Enforcement Division
Medicines Control Authority of Zimbabwe
Zimbabwe

Industry
(primary representative)

Nil

Industry
(secondary representative)

Nil